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IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595300820
Basic UDI-DI: 4987595PATHFASTSC
Reference: 300820
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

FIAflex Fluorescent Immunoassay Analyzer(iFIA-800)

iFIA-800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756471730
Basic UDI-DI: 6921756499990101WU
Reference: F113-10111-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

QUIK-CHECK Ultra Cholesterol Meter

CCM-101

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497637
Basic UDI-DI: 6921756499990069XR
Reference: C111-5037-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mission Cholesterol Meter

CCM-111

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756475222
Basic UDI-DI: 6921756499990065XH
Reference: C111-2021-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

On Call GK Dual Blood Ketone Meter

OGM-161

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756471125
Basic UDI-DI: 6921756499990082XH
Reference: GN115-111-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

On Call GU Dual Blood Glucose & Uric Acid Meter

OGM-201

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470258
Basic UDI-DI: 6921756499990049XK
Reference: GU114-11D-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

QUIK-CHECK Cholesterol Meter

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497958
Basic UDI-DI: 6921756499990065XH
Reference: C111-2027-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:16

Manufacturer products Authorised representative products Authorised representative actors View details

Mission Ultra Cholesterol Meter

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497996
Basic UDI-DI: 6921756499990069XR
Reference: C111-5031-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:16

Manufacturer products Authorised representative products Authorised representative actors View details

PRIVA Cholesterol Meter

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497668
Basic UDI-DI: 6921756499990069XR
Reference: C111-5033A-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:16

Manufacturer products Authorised representative products Authorised representative actors View details

Flowflex Fluorescent Immunoassay Analyzer(iFIA-800)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756472324
Basic UDI-DI: 6921756499990101WU
Reference: F113-10115-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:16

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Astrabio Technology Co., Ltd.
Manufacturer SRN: CN-MF-000041763
UDI-DI: 06977100860190
Basic UDI-DI: 697710086ASTDFL8
Reference: 8900018200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 23.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

06935784460020

BF-300

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460020
Basic UDI-DI: B-06935784460020
Reference: BF-M11
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784460013

BF-100

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460013
Basic UDI-DI: B-06935784460013
Reference: BF-M31
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cholesterol Meter

IVD Class ANot specifiedOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061027264436
Basic UDI-DI: 5060599401942YP
Reference: RL-CHOM-1AS
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M347S

BF-130

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-M347S
Basic UDI-DI: B-CNMF000014455-BF-M347S
Reference: BF-M34
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M337Q

BF-120

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-M337Q
Basic UDI-DI: B-CNMF000014455-BF-M337Q
Reference: BF-M33
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M327N

BF-110

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-M327N
Basic UDI-DI: B-CNMF000014455-BF-M327N
Reference: BF-M32
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M227K

BF-331

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-M227K
Basic UDI-DI: B-CNMF000014455-BF-M227K
Reference: BF-M22
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M217H

BF-330

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-M217H
Basic UDI-DI: B-CNMF000014455-BF-M217H
Reference: BF-330
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M147L

BF-031

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-M147L
Basic UDI-DI: B-CNMF000014455-BF-M147L
Reference: BF-M14
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details